One interesting aspect of the recent Federal Circuit decision in Association for Molecular Pathology v. USPTO, is the apparent scientific basis for the differing opinions of Judge Lourie and Judge Bryson on the patent-eligibility of isolated genomic DNA claims. Unlike many concurring and dissenting opinions that are spurred by a different view of the law, Judge Lourie and Judge Bryson also appear to part ways based on different views of the science.
In this first part of a three-part series, I focus on the views of Judge Lourie.
The Significance Of Breaking Covalent Bonds
As I wrote previously, Judge Lourie's opinion for the court upheld the patent-eligibility of "isolated DNA" claims, applying the "breaking covalent bonds" test that Judge Lourie had raised during oral argument.
Isolated DNA has been cleaved (i.e., had covalent bonds in its backbone chemically severed) or synthesized to consist of just a fraction of a naturally occurring DNA molecule. . . . Accordingly, BRCA1 and BRCA2 in their isolated state are not the same molecules as DNA as it exists in the body; human intervention in cleaving or synthesizing a portion of a native chromosomal DNA imparts on that isolated DNA a distinctive chemical identity from that possessed by native DNA.
With a Ph.D. in chemistry, Judge Lourie certainly understands chemistry. With this background in mind, it is easy to understand why the breaking of covalent bonds holds such meaning for him. Responding to Judge Bryson's dissent, he explained:
[A] covalent bond is the defining boundary between one molecule and another. . . .The covalent bonds in this case separate one chemical species from another.
However, both Judge Moore and Judge Bryson suggest that Judge Lourie's emphasis on covalent bonds arbitrarily draws a line that distinguishes covalent bonds from other chemical interactions, such as hydrogen bonds and ionic bonds.
Different Structure More Important Than Similar Function
Judge Lourie criticized the district court's treatment of DNA as a "physical embodiment of information" for elevating function over structure.
[T]he district court disparaged the patent eligibility of isolated DNA molecules because their genetic function is to transmit information. We disagree, as it is the distinctive nature of DNA molecules as isolated compositions of matter that determines their patent eligibility rather than their physiological use or benefit. Uses of chemical substances may be relevant to the non-obviousness of these substances or to method claims embodying those uses, but the patent eligibility of an isolated DNA is not negated because it has similar informational properties to a different, more complex natural material that embodies it. The claimed isolated DNA molecules are distinct from their natural existence as portions of larger entities, and their informational content is irrelevant to that fact.
Speaking more generally, Judge Lourie wrote:
We recognize that biologists may think of molecules in terms of their uses, but genes are in fact materials having a chemical nature and, as such, are best described in patents by their structures rather than their functions.
The Shortcomings Of DOJ's Magic Microscope Test
Judge Lourie was critical of the Department of Justice's "magic microscope" test for overlooking the significant inventive activity that can be required to obtain isolated DNA.
Because isolated DNAs, not just cDNAs, have a markedly different chemical structure compared to native DNAs, we reject the government’s proposed "magic micro-scope" test, as it misunderstands the difference between science and invention and fails to take into account the existence of molecules as separate chemical entities. The ability to visualize a DNA molecule through a microscope, or by any other means, when it is bonded to other genetic material, is worlds apart from possessing an isolated DNA molecule that is in hand and usable. It is the difference between knowledge of nature and reducing a portion of nature to concrete form, the latter activity being what the patent laws seek to encourage and protect. . . .
One cannot visualize a portion of a complex molecule, including a DNA containing a particular gene, and will it into isolation as a unique entity. Visualization does not cleave and isolate the particular DNA; that is the act of human invention.
Hypothetical Analogies Not Persuasive
Judge Lourie stood his ground on the "elemental lithium" analogy that was discussed at oral argument:
[I]f lithium is found in the earth as other than elemental lithium, such as "in molecular form" "because it reacts with air and water," it is not the same material as elemental lithium.
Judge Lourie expressed little patience for the "isolated leaf" analogy raised by Judge Dyk in his separate opinion in Intervet Inc. v. Merial Ltd.:
With respect, no one could contemplate that snapping a leaf from a tree would be worthy of a patent, whereas isolating genes to provide useful diagnostic tools and medicines is surely what the patent laws are intended to encourage and protect. Snapping a leaf from a tree is a physical separation, not one creating a new chemical entity.
Thus, Judge Lourie rests his views of patent-eligibility on his conclusion that "isolated DNA" molecules have "a distinctive chemical identity" as compared to genomic DNA as it occurs in nature, and likely would reach the same conclusion about other "isolated" species that differ structurally from "the native element, molecule, or structure."